Kornimate/medical-research-clean huggingface dataset:
follow-up study in french practice to evaluate improvements in walking and pain relief in patients treated with endovascular treatment of de novo lesions of the femoropopliteal artery above the knee with lutonix®035 or ranger tm active ballon

Conditions: Drug-coated Balloon Catheter

Summary: this study is part of the subordination for the renewal of the registration of the lutonixr035 or rangertm drug coated balloon catheter by the cnedimts following the transmission of the results of a french study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with lutonixr035 or rangertm drug-coated balloon catheters. in accordance with the has practical guide on the approval of medical devices in france (november 2017), the protocol for this study was submitted in advance to the has and its suggestions were taken into account when drafting the objectives relative to the population to be included. a second exhaustive study will be conducted in parallel using snds data to complete the cnedimts application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.


Eligibility criteria:
inclusion criteria: * patient having given express oral consent * patient to be treated by endovascular procedure with a lutonixr035 or ranger tm drug coated balloon catheter according to the recommendations of the ansm dated 13/05/2019 1 and possible updates of these recommendations. exclusion criteria: * pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice) * adult unable to express consent * patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...) per-intervention exclusion criteria * patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent. * patient operated on but for whom the balloon was not used during the procedure * patient operated but for whom another balloon than those under study was finally used during the operation
prognostic biomarker for crc

Conditions: Colorectal Cancer

Summary: the purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

this is a prospective observational study. tumor tissue specimens and surgical specimens are obtained from the sixth affiliated hospital, sun yat-sen university. the samples are analyzed for biomarkers. the biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death). the aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . this will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. colon or rectal cancer diagnosed by endoscopic biopsy histopathology; 2. complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.; 3. sufficient surgical tissue samples are available for testing; 4. untreated colon or rectal cancer patients; 5. patient able to understand and sign written informed consent 6. no evidence of distant metastasis (m0) exclusion criteria: 1. previously treated crc, including cytotoxic drug therapy, targeted drug therapy, etc.; 2. other malignant tumors; 3. pregnant women; 4. hereditary colorectal cancer linked to familial colonic polyposis or lynch syndrome
phase ii study of weekly paclitaxel (bms-181339)in patients with advanced or recurrent esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this clinical research study is to learn if bms-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * patients must have measurable disease * patients must have experienced on pervious chemotherapy regime * men and women, with the age 20 years or older * ecog ps: 0-1 exclusion criteria: * patients with previous therapy with taxanes
efficacy of radiotherapy in combination with zoledronic acid in bone metastasis patients with gastrointestinal tumors

Conditions: Bone Metastasis; Gastrointestinal Cancer

Summary: bone metastasis causes bone destruction and skeletal related events (sre) including compression fracture, hypercalcemia, and spinal cord compression. therefore, palliative treatments for pain control and local control have become important and multidisciplinary multimodality approach is needed for treatment of bone metastasis. the efficacy of radiotherapy (rt) for bone metastasis is well known. and the results that bisphosphonate decreases sre in patients with solid tumor and multiple myeloma reported. in previous retrospective reports, the combination of local rt and systemic bisphosphonate was more effective than rt alone. therefore, investigators designed a phase ii study to evaluate the efficacy of rt in combination with zoledronic acid on pain relief and the safety of rt in bone metastasis patients with gastrointestinal tumors.


Eligibility criteria:
inclusion criteria: * patients with radiologic detectable bone metastasis (spine or non-spine) * patients with clinical diagnosis of gastrointestinal cancer: esophagus, stomach, colorectum, anus, liver, pancreas, gallbladder, biliary tract, etc. * patients over 20 years of age of both genders * ecog: 0 \~ 2 * pain: worst pain score on bpi ≥3 exclusion criteria: * undetectable bone metastasis on radiologic study * patients who have previous surgery history at same site * patients who are considered surgery first: pathologic fracture, neurological or radiological evidence of spinal cord compression, impending pathologic fracture * patients who have hypersensitivity for zoledronic acid or other bisphosphonate * patients who have treatment history with zoledronic acid or other bisphosphonate * abnormal renal function or history of kidney transplantation * patients with metabolic bone disease * synchronous symptomatic brain metastasis * women who are pregnant, breast-feeding, or possible pregnancy
a study to evaluate zilebesiran in japanese patients with mild to moderate hypertension

Conditions: Mild to Moderate Hypertension

Summary: the purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (pd) and pharmacokinetics (pk) of zilebesiran in japanese patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * must have been born in japan, and their biological parents and grandparents must have been of japanese origin * has mean systolic office blood pressure (sbp) of \>130 and \<=165 mmhg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication * has 24-hour mean sbp ≥130 mmhg by ambulatory blood pressure monitoring (abpm), without antihypertensive medication exclusion criteria: * has secondary hypertension, symptomatic orthostatic hypotension * has alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2× upper limit of normal (uln) * has elevated serum potassium \>5 mmol/l * has estimated glomerular filtration rate (egfr) of \<60 ml/min/1.73m\^2 * has received an investigational agent within the last 30 days * has type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus or newly diagnosed type 2 diabetes mellitus * has history of intolerance to sc injection(s)

Keywords: high blood pressure hypertension hypertensive sirna angiotensinogen agt
neuragen for peripheral diabetic neuropathy

Conditions: Diabetic Peripheral Neuropathy; Diabetic Neuralgia

Summary: the purpose of this study is to determine if the use of neuragen (a natural health product oil rubbed into the skin) is effective at reducing pain and improving the quality of life in people with diabetic peripheral neuropathy.

incidence of diabetic neuropathy and development of diabetic ulcers varies based on the severity (lack of blood sugar control) and duration of diabetes. estimates of rates of occurrence vary although one prospective study showed 7.2% of newly diagnosed ulcer-free diabetics developed ulcers within one year of being diagnosed. current treatment initiatives aimed at educating diabetic patients on how to prevent diabetic ulcers and mange peripheral neuropathy have had varied success. chronic pain is the number one reason that this population seeks help from medical professionals. diabetics are particularly predisposed to a potentially disabling form of chronic pain known as peripheral neuropathy. in fact, over 50% of diabetics have painful neuropathy, or will develop this condition. other than the primary goal of addressing blood sugar levels, conventional treatment of diabetic peripheral neuropathy involves prescription gabapentanoids or opiod analgesics, both of which have considerable cost and may be associated with side effects from long-term use and overall limited success rates. neuragen is an over-the-counter natural health product that may be a safe and effective treatment option for this disease. using a randomized double-blind placebo control clinical trial the effects of neuragen on pain, function and quality of life will be assessed.

Eligibility criteria:
inclusion criteria: * men and women of at least 18 years of age * established diagnosis of neuropathic pain for at least the past 3 months duration, and type 1 or type 2 diabetes, confirmed by primary care physician and/or neurologist. by signing the informed consent, participants agree to have the study coordinator contact their physician for confirmation of diagnosis. * pain of at least level 4 on a 0-10 scale, and not over 9, despite other treatments on intake. * presence of dynamic tactile allodynia or pinprick hyperalgesia * normal cognitive and communication skills (as judged by investigator) and ability to complete self-report questionnaires. exclusion criteria: * pregnancy * previous or continuing use of neuragen® * evidence of other types of pain as, or more severe, than the pain under study * major psychological conditions requiring treatment * history of eczema/atopy/anaphylaxis or unusual skin reactions. this will be assessed using a subjective question (have you ever suffered from eczema? or experienced a skin reaction to a substance? or experienced an anaphylactic reaction?) * self reported sensitivity to perfumes, essential oils, odors. * changes to current pain management regime within the previous month prior to start of study.

Keywords: diabetic peripheral neuropathies neuralgia complementary medicine analgesia
olga and olgim stage system for gastric cancer

Conditions: Stomach Neoplasms; Atrophic Gastritis; Intestinal Metaplasia

Summary: to validate olga and olgim staging system with serum pepsinogen for estimating gc risk according to lauren's histologic classification in south korea. also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

to validated the olga and olgim staging system with serum pepsinogen to estimate gastric cancer risk according to lauren's histologic classification in south korea, where the incidence rate of gc is high. in addition, the investigators attempted to investigate the interaction among the several risk factors including olga or olgim staging system for the risk of gc to help establish surveillance strategy.

Eligibility criteria:
inclusion criteria: * control group * those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and maltoma in upper gastrointestinal endoscopy * gastric cancer group * patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old. exclusion criteria: * history of previous gastrointestinal surgery, * any other malignancy * cardia cancer * who do not perform endoscopic biopsy * pathologically proven gastric dysplasia

Keywords: olga olgim helicobacter pylori gastric cancer pepsinogen
prevalence of osa in patients of ild

Conditions: OSA

Summary: to evaluate the clinical predictors of osa in patients with ild

interstitial lung diseases (ilds) are a group of heterogeneous disorders characterized by varying degrees of fibrosis and inflammation of lung parenchyma. obstructive sleep apnea is a type of sleep disordered breathing characterized by repeated episodes of apnea and hypopnea during sleep due to narrowing or occlusion of the upper airway. it was found that the prevalence of osa is as high as 80% among patients with idiopathic pulmonary fibrosis (ipf). despite this common association, there is limited research in this field. there is great need for further studies to highlight this association and understand the underlying pathophysiological mechanisms implicated in those patients, to ultimately guide the appropriate management.

Eligibility criteria:
inclusion criteria: * patients presented to chest department with interstitial lung disease will be included, screened for osa. exclusion criteria: * age: less than 18 years. unstable patients or need for icu admission
immune molecular and inflammatory cytokines dysfunction analysis in gout patients with different urate levels

Conditions: Primary Gout

Summary: the aim of study was to assess the efficiency and safety of oral il-1βinhibitor in combination with urate lowering therapy on joint pain intensity,urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers and symptoms improving related life quantity in gouty patients.

this was a randomized single-dose, open-label and active-controlled study which was carried out in 96 primary gout patients. subjects and doctors have no access to randomization sequence which is determined by the primary investigator.all patients received an open-label febuxostat 40mg daily during the whole study. healthy control were 32 age-matched men from volunteers in the medical health center.two primary end points included pain intensity measurement which was recorded at each visit and subsequently acute flare times which was recorded at home and reported to investigator.

Eligibility criteria:
inclusion criteria: all participants who were allocated to the study all had a history of taking tolerable and adequate dose of urate lowering therapy including febuxostat 40-80mg daily or allopurinol 200-300 mg daily for at least 4 weeks and were defined as difficult to treat or refractory gout patients. all patients had a negative of rheumatoid factor and antinuclear antibody, hb\>100g/l, total leukocyte count≥3.5×109, plt≥80×109, serum creatinine\<133umol/l, transaminases\<60u/l and fasting urate≥6.0mg/dl. inclusion criteria for the gouty patients were age≥18 years old, bmi(18-30kg/m2). all participants enrolled in our study fulfilled american college of rheumatology criteria for primary gout. exclusion criteria: exclusion criteria included secondary gout (because it is always associated with some underlying renal disease), a history of congestive heart failure, serum creatinine≥133umol/l (because the patients have underlying risks if nsaid needed) or the use of glucocorticoid\>15mg daily,colchicine, uricosuric drugs, chemotherapy or immunosuppressive therapy in the past three months.
switch or sequential combination therapy of peginterferon in hepatitis b patients with longterm entecavir therapy

Conditions: Chronic Hepatitis B

Summary: this is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis b patients with low hbsag and hbeag titers after long-term entecavir therapy, and compared to those who continued on etv therapy.

chronic hepatitis b (chb) infection remains a global health treat. the ideal end point of therapy is hbsag loss or hbsag seroconversion, indicating a complete remission of chb. in patients with hbeag-positive chb, sustained hbeag seroconversion is also a desirable end point. current therapies include pegylated interferon (pegifn) finite and nucleos(t)ide analogues (nucs) longterm therapy. however, only 30-40% of patients may achieve hbeag seroconversion on pegifn monotherapy, whereas 15-20% of patients on entecavir (etv). recently, accumulating evidence had shown that optimization of switching or combining pegifn in patients on long-term etv therapy may increase rate of hbeag seroconversion and even lead to the complete eradication of hbv. however, these two regimens has not been tested adequately in patients with low hbsag/hbeag titers on long-term etv therapy. this is a multicenter, prospective cohort study to evaluate the efficacy and safety of sequential combination or switch therapy of pegylated interferon alfa-2a in chronic hepatitis b patients with low hbsag and hbeag titers after long-term entecavir therapy, and compared to those who continued on etv therapy.

Eligibility criteria:
inclusion criteria: * male and female patients \> 18 and ≤ 60 years of age; * positive hbsag for more than 6 months; * patients receiving previous etv therapy ≥2 years; * patients who have achieved undetectable hbv dna, hbsag \<1500iu/ml and hbeag \<200s/co prior to switch or s-c therapy; * alt\<=10\*uln and tb\<2\*uln; * patients who have been assigned to treatment with pegifn (s-c or switch) or continuous etv after previous etv therapy exclusion criteria: * evidence of decompensated cirrhosis or hepatocellular carcinoma; * serological evidence of co-infection with hcv, hdv or hiv; * pregnant or breast-feeding women; * patients with diseases that might contraindicate to pegifn therapy including severe psychiatric diseases, immunological diseases, severe retinopathy, thyroid dysfunction, leukocytopenia, thrombopenia, etc * patients receiving concomitant therapy with telbivudine; * a history of drug or alcohol abuse; * other conditions that investigates consider not suitable for participate

Keywords: pegylated interferon entecavir
assessment of the nutritional status of children and adolescents with malignancies

Conditions: Malnutrition

Summary: the main objective of this study was the assessment of the nutritional status of children and adolescents aged between 0-18 with malignancies based on bmi percentiles and standard deviation scores, at diagnosis, during treatment and during a period of two years after the end of therapy.

children and adolescents suffering from malignancies often show malnutrition. malnutrition, defined as a deficiency or an excess of energy, is associated with an increased risk of comorbidities, reduced survival rates, higher relapse rates, and worse treatment response. the present retrospective study assessed the nutritional status of children and adolescents, suffering from nine different kinds of cancer, based on bmi percentiles and standard deviation scores. anthropometric data were recorded from clinical charts and an assessment of the nutritional status was made at the beginning of treatment, during the course of therapy and during a follow-up period of two years. the influence of treatment-related characteristics, the duration of therapy, and the occurrence of a relapse or progress during therapy on the nutritional status were examined.

Eligibility criteria:
inclusion criteria: * children and adolescents treated at the olgahospital stuttgart for one of the nine different cancer types * treated according to a study protocol of the society of pediatric oncology and hematology (gpoh), with modifications only allowed within the therapeutic protocol * time period between diagnosis and start of treatment less than 28 days * age younger than 18 exclusion criteria: * severe underlying disease, which exerts a strong influence on weight and/or height * patients whose clinical record does not state any weight and/or height * diseases which are not considered as malignant because of the state or biology

Keywords: children and adolescents cancer malnutrition bmi percentile bmi-sds
efficacy and safety evaluation of paxlovid for covid-19: a real-world case-control study

Conditions: COVID-19 Pneumonia

Summary: covid-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. paxlovid is a pfizer-developed oral new drug for the treatment of covid-19. paxlovid, which is used to treat adult patients with mild to moderate covid-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the united states and china in december 2021 and february 2022, respectively. clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. however, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of paxlovid in a real-world population. relevant studies on this drug in real-world people, especially in chinese populations, have not been reported. therefore, this study was designed to investigate the efficacy and safety of paxlovid on sufferers of covid-19 through a retrospective, real-world analysis.


Eligibility criteria:
inclusion criteria: * patients with confirmed covid-19 who had taken more than one dose of paxlovid. exclusion criteria: * age \< 18 years-old; * pregnancy; * data missing \> 20%.